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Trial Outcomes & Findings for Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (NCT NCT00613314)

NCT ID: NCT00613314

Last Updated: 2014-05-26

Results Overview

Response rate of Blood Pressure assessed in the following categories: * Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline * Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Recruitment status

COMPLETED

Target enrollment

15268 participants

Primary outcome timeframe

End of 30 day Period

Results posted on

2014-05-26

Participant Flow

The protocol specified that the study will consist of 16,000 subjects. However, there are only 15, 268 case report forms (CRFs) submitted

Participant milestones

Participant milestones
Measure
Telmisartan (Micardis)
Overall Study
STARTED
15268
Overall Study
COMPLETED
15113
Overall Study
NOT COMPLETED
155

Reasons for withdrawal

Reasons for withdrawal
Measure
Telmisartan (Micardis)
Overall Study
Adverse Event
5
Overall Study
Protocol Violation
14
Overall Study
Lost to Follow-up
46
Overall Study
Other reason not defined above
90

Baseline Characteristics

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Telmisartan (Micardis)
n=14161 Participants
Age, Continuous
59 Years
STANDARD_DEVIATION 9.9 • n=93 Participants
Gender
Female
8253 Number of participants
n=93 Participants
Gender
Male
5876 Number of participants
n=93 Participants

PRIMARY outcome

Timeframe: End of 30 day Period

Population: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Response rate of Blood Pressure assessed in the following categories: * Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline * Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Outcome measures

Outcome measures
Measure
Telmisartan (Micardis)
n=14161 Participants
Response Rate at the End of 30 Day Period
Sitting SBP response
41.4 Percentage of patients
Response Rate at the End of 30 Day Period
Sitting DBP response
66.3 Percentage of patients
Response Rate at the End of 30 Day Period
Sitting BP normalization
31.2 Percentage of patients

PRIMARY outcome

Timeframe: At the end of 60 day period

Population: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Response rate on Blood Pressure: 1. Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline. 2. Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline. 3. Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Outcome measures

Outcome measures
Measure
Telmisartan (Micardis)
n=14161 Participants
Response Rate at the End of 60 Day Period
Sitting SBP response
75.5 Percentage of patients
Response Rate at the End of 60 Day Period
Sitting DBP response
88.1 Percentage of patients
Response Rate at the End of 60 Day Period
Sitting BP normalization
69.1 Percentage of patients

PRIMARY outcome

Timeframe: Baseline and 60 days

Population: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Outcome measures

Outcome measures
Measure
Telmisartan (Micardis)
n=14161 Participants
Change in Systolic Blood Pressure (SBP) From Baseline
30.2 mmHg
Standard Deviation 15.4

PRIMARY outcome

Timeframe: Baseline and 60 days

Population: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Outcome measures

Outcome measures
Measure
Telmisartan (Micardis)
n=14161 Participants
Change in Diastolic Blood Pressure (DBP) From Baseline
15.9 mmHg
Standard Deviation 10

SECONDARY outcome

Timeframe: At the end of 60 day period

Population: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely: a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities, based on patients' Medical History

Outcome measures

Outcome measures
Measure
Telmisartan (Micardis)
n=14161 Participants
Percentage of Patients With Presence of Metabolic Risk Factor
20.0 Percentage of patients

Adverse Events

Telmisartan (Micardis)

Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Telmisartan (Micardis)
n=15268 participants at risk
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.01%
2/15268 • Upto 60 Days
Gastrointestinal disorders
DIARRHEA
0.01%
1/15268 • Upto 60 Days
Investigations
HIGH BLOOD PRESSURE (190/120)
0.01%
1/15268 • Upto 60 Days
Respiratory, thoracic and mediastinal disorders
MASSIVE HEMOPTYSIS
0.01%
1/15268 • Upto 60 Days

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Pharmaceuticals

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
  • Publication restrictions are in place

Restriction type: OTHER